Ning Yibao, former director of the Technical Research Office of China Veterinary Drug Administration

Achievements and prospects of veterinary vaccine industry in China

From the founding of New China to the present, especially in the past 30 years of reform and opening up, China's animal husbandry has made rapid development. The animal husbandry has accounted for about 40% of the total agricultural output value. The rapid development of animal husbandry has effectively solved the urban and rural residents' meat and milk. The supply problem has enabled hundreds of millions of farmers engaged in aquaculture to achieve poverty alleviation and prosperity. However, China's animal infectious diseases seriously endanger the development of animal husbandry, and it is impossible to effectively control animal infectious diseases. The healthy development of animal husbandry cannot be discussed. The most effective way to effectively prevent and control animal infectious diseases is to use veterinary vaccines for immunization. Thus, veterinary vaccines play a pivotal role in protecting the healthy development of animal husbandry. Since the reform and opening up, with the rapid development of the aquaculture industry, the party and the government have attached great importance to it, and China's veterinary vaccine industry has undergone earth-shaking changes. By 2016, China's veterinary vaccine production enterprises have exceeded 100, of which large and medium-sized enterprises accounted for 84%, fixed assets reached 27 billion yuan, 7 companies listed on the main board in Shanghai and Shenzhen, employing more than 20,000 people, 2016 The sales volume of veterinary vaccines has reached more than 160 billion yuan, and the production and use of vaccines ranks first in the world. Whether in research and development, production or use, it is a veritable veterinary vaccine country and a strong country. For the weak and small industries that were not seen before the reform and opening up, today it is a new type of industry with great potential to reach the international advanced level. It is a historic leap development. Specifically in:

The scale and capacity of veterinary vaccine production has increased significantly

In 2015, more than 100 veterinary vaccine companies have passed the veterinary drug GMP acceptance, and the plant facilities have reached the international first-class level, with an annual production capacity of 600 billion heads (feathers). The hardware and production management software for the veterinary production enterprises, such as plant facilities, personnel quality, raw materials and production environment, must meet the requirements of veterinary drug GMP. At present, the production scale and actual production capacity of veterinary vaccines in China have surpassed that of any country in the world.

However, in the early 1950s, there were only seven small veterinary biopharmaceutical plants in Nanjing, Chengdu, Lanzhou, Jiangxi, Guangxi, Kaifeng and Harbin. In 1979, before the reform and opening up, the total number of veterinary biopharmaceutical manufacturing plants in China reached 28, covering all major provinces; the facilities and facilities were simple, and none of them reached the GMP standard for veterinary drugs, with a production capacity of 60 billion heads.

Significant improvement in vaccine production process

At present, the production process of most vaccines in China has reached the international advanced level, and the standardization of raw materials for vaccine production has been basically realized. The advanced vaccine production technology of biological fermentation and cell suspension culture has been widely used, and the whole process of production of main veterinary vaccines is basically Automated.

In the production process of live vaccines, manufacturers have established uniform standards in seed preparation, antigen propagation and harvesting, and vaccine testing in chicken embryo inoculation, vaccine harvesting, dispensing, lyophilization, vacuuming, glanding and labeling. The other links have basically achieved automation; bacterial organism fermentation culture, viral cell microcarriers or full suspension culture have been widely used in some products, and effectively solve the problem of vaccine freeze-dried protective agent; in the inactivated vaccine, It also solves the automatic process of chicken embryo inoculation, cell suspension culture, vaccine harvesting, antigen concentration, dispensing and emulsification, the breakthrough of vaccine immunoadjuvant and the use of immunopotentiator, which greatly improves the immune efficacy of inactivated vaccine;

Before the reform and opening up, China's vaccine production was mainly manual, with backward technology, high labor intensity, low output and high cost.

There are many varieties of veterinary vaccine products, and the categories are complete.

By the end of 2016, more than 660 products have been registered with the Ministry of Agriculture for new veterinary drugs. The vaccine is available in a variety of varieties.

In 2010-2016 alone, nearly 200 vaccine products were awarded by the Ministry of Agriculture for new veterinary drug certificates. In the statistics, 77 vaccine companies have a total of 1592 product approval numbers, including 936 poultry products, 462 pig products, 128 cattle and sheep products, 46 pets and other animals, and rabbit products. One. It basically meets the needs of disease prevention and control of all livestock and poultry species.

In 1952, there were only 18 varieties of veterinary vaccines in China.

In 1979, there were not more than 100 species.

The production of vaccines has increased steadily and the quality has been continuously improved.

In 2015, the sales volume of veterinary vaccines in China totaled more than 160 billion heads (feathers), and the output exceeded that of any country in the world. The product qualification rate has increased year by year. In recent years, the qualified rate of veterinary vaccine products has remained stable at over 95%. Most products have reached the international advanced level. China has become a major producer of veterinary vaccines.

In 1952, the annual output of veterinary biological products in China was only 120 million heads (feathers).

In 1979, the annual production of vaccines was less than 2 billion heads (feathers).

Science and technology innovation has a good foundation, strong ability, and strong enough

(1) Research and development institutions: As of 2015, we have 8 national veterinary vaccine research units, nearly 40 provincial veterinary research institutes; more than 30 national, provincial and ministerial key open laboratories, and some agricultural colleges. Colleges and universities are engaged in research on veterinary vaccines.

(2) R & D personnel: Most of the veterinary vaccine companies have their own research and development institutions, with 2,486 R&D personnel, of which 28.3% have intermediate titles and 11% have senior titles, and the research team is obviously growing;

(3) Significant increase in scientific research investment: In 2015, R&D capital investment reached 980 million yuan, accounting for 9.15% of annual sales, reaching a record high.

(4) The level of scientific research is constantly improving: China not only uses traditional techniques to study new vaccines, but also uses modern molecular techniques to study vaccines. A batch of vaccines created with genetic engineering technology has been put on the market and played an important role in the prevention and control of animal infectious diseases. China's research on a variety of vaccines such as swine fever and avian influenza vaccines is at the international leading level, playing an extremely important role in the effective prevention and control of animal infectious diseases.

Almost every National Science and Technology Progress Award has won awards for research on veterinary vaccines.

  Opportunities and Challenges

Although China's veterinary vaccine industry has achieved such great achievements, there are still many uncertainties in the emergence of new animal infectious diseases and the variation of old animal infectious diseases. There are still some problems on the way forward that we need to take seriously. Solved, mainly in:

(1) New animal infectious diseases are constantly appearing, and there is still great pressure on the development of new vaccines. In the short period of time after entering the 21st century, with major pathogenic diseases such as highly pathogenic avian influenza, Streptococcus suis type 2 disease, Asian type I foot-and-mouth disease, highly pathogenic blue ear disease and small ruminant plague The occurrence and prevalence caused great losses to the livestock industry. To effectively control these new animal infectious diseases and reduce the losses of the breeding industry, it is urgent to produce safe and effective vaccines for graduate students in a short period of time.

(2) The pathogens of animal infectious diseases are constantly mutating, and the original vaccine immune effect is significantly reduced or ineffective. Traditional prevention and control methods have encountered new problems, and it is urgent to study new vaccines. Some diseases that have been controlled have mutated due to the structure of the antigen, resulting in the reduction or ineffectiveness of the original vaccine immunity of some animal infectious diseases. Disease prevention and control has become more difficult. It is urgent to improve the quality of the original vaccine and research new vaccines. .

3. The upgrading of traditional products is extremely urgent. Some veterinary vaccine products with backward production process have high labor intensity, low yield, high cost and poor immune effect, and need to improve the production process to improve vaccine yield and quality.

New vaccines need to go through a complicated process from research to use. In general, new infectious diseases are always present, vaccines are already in place, and new infectious diseases are inevitably given to livestock before new animal vaccines are put into use. The economic development of the industry causes heavy or light economic losses, and some losses may be devastating to the livestock industry. This requires us to identify the pathogens based on the prevalence of new infectious diseases and the pathogenic variability of existing infectious diseases, timely research and promote the use of safe and effective veterinary vaccines; use modern biotechnology to transform traditional vaccines and improve Vaccine safety and immune efficacy.

With the continuous improvement of people's living standards, people not only pay attention to the quantity of animal products, but also pay more attention to quality and safety. Therefore, effectively controlling animal infectious diseases and providing more high-quality and safe animal products to the society is the reform of the supply side of animal husbandry. The main task.

We must constantly summarize the theoretical knowledge and practical experience accumulated over the years in the development of veterinary vaccines at home and abroad, make better use of modern biotechnology to guide the research and production of veterinary vaccines, comprehensively improve the yield and quality of veterinary vaccines in China, and continuously increase new varieties. To make the vaccine play a better role in the prevention and control of animal diseases, and to greet the victory of the party's 19th National Congress with excellent results.